Medical Affairs Director Resume Sample
Ova Gottlieb
8134 Chaim Rue,
Boston,
MA
+1 (555) 912 4341
Work Experience
Medical Affairs Director
09/2015
-
PRESENT
San Francisco, CA
- To represent the unified EMEA voice
- To shape Global MA Strategy for the product
- To input into the CDT, including input into phase II/ III designs, and country and site selection
- To input into the Global Clinical Program with the aim to reach alignment and avoid duplication or conflicting clinical projects
- To provide input on the breakthrough research in line with the unmet medical / social needs in EMEA region
- To provide input into phase I designs
- To provide input into publication plans
- To provide input into Medical Educations plan / activities in the EMEA region
Medical Affairs Director Dermatology
10/2012
-
03/2015
New York, NY
- >8 years experiences in pharmaceutical industry
- Robust clinical and/or medical affairs experience in role relevant (Heart Failure)
- Previous experience of leading and influencing an international team
- Experience in a medical role at country level as well as a regional and/or global role
- Demonstrated ability to establish strong scientific partnership with key investigators in role relevant (Heart Failure)
- MAIN ACTIVITIES/TASKS
- For the assigned Medical Affairs studies (Phase IIIB-IV, Post Marketing Surveillance, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the Global Medical Affairs Director provides medical scientific input to, e.g.
- For the assigned Medical Affairs studies (Phase IIIB-IV, Publication Management System (PMS), non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the GMA Director provides medical scientific input to, e.g.
- Build together with the Global Brand Medical Director (GBMD) Medical Affairs strategy
Regional Medical Affairs Director
03/2006
-
05/2012
Boston, MA
- Build together with the Global Brand Medical Director Medical Affairs strategy a. Provide support on the Medical Affairs Plan and other lines functions plans (Clinical Development Plan, Integrated Product Strategy, etc.) b. Provide input on scientific content of Program/brand(s) publication plan c. Support/lead data mining and Real World Evidence (RWE) activities
- Leadership over the global Agilent Medical Affairs function
- Serves as the Agilent Medical Director and considered internally and externally as an expert medical opinion in pathology
- Respected licensed pathologist that has the ability to represent Agilent in meetings with pharmaceutical clients, partners and medical KOLs
- Develops, implements and maintains the global organizational medical affairs strategies and activities including the development and maintenance of medical affairs procedures and processes
- Develops health hazard analyses for identified potential product/patient risks and/or clinical use failure modes, clinical risk benefit analyses associated with new product introduction and/or new product indications for use, and medical support of clinical trials
- Builds up of an efficient organization that supports premarket, post market and medical affairs activities and operations including but not exclusive to: the development of clinical use and patient risks analyses, post market clinical utility summaries, clinical summaries in product annual reports, and complaint vigilance and recall health hazard assessments
- Evaluate current medical affairs processes & procedures and implement new and necessary improvements and additions
- Support current development and partner programs including companion diagnostics, representing Agilent when appropriate as medical KOL
Education
Everest University - Tampa Campus
2000 - 2005
Science's Degree in Business
Professional Skills
- Demonstrated analytical skills; analytical thinker with excellent problem solving skills
- Strong scientific analytical and problem solving skills, strategic capabilities, project management and planning skills
- Strong project management skills with proven experience in meeting timelines
- Demonstrated leadership ability and experience managing performance
- Demonstrated ability to adapt to changing priorities and deadlines
- Capable of leading a large multinational team based remotely. Building strong working relationships and motivating teams to deliver outstanding results
- Experience in giving high level presentations externally and internally
How to write Medical Affairs Director Resume
Medical Affairs Director role is responsible for research, english, training, integration, oncology, planning, reporting, manufacturing, design, travel.
To write great resume for medical affairs director job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Medical Affairs Director Resume
The section contact information is important in your medical affairs director resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Medical Affairs Director Resume
The section work experience is an essential part of your medical affairs director resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous medical affairs director responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular medical affairs director position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Medical Affairs Director resume experience can include:
- Advanced skills in English both written and spoken
- Medical science background with a strong understanding of clinical research and clinical trial design and management
- Surgical experience in a predominantly bariatric practice offering a range of bariatric procedures
- Scientific leadership: Overall responsibility for the development, prioritization and delivery of the Medical Affairs Plans (MAP) that address identified gaps
- Providing training to APOC staff
- Willing to travel globally as required to meet job expectations estimated at 33%
Education on a Medical Affairs Director Resume
Make sure to make education a priority on your medical affairs director resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical affairs director experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Medical Affairs Director Resume
When listing skills on your medical affairs director resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical medical affairs director skills:
- Strong oral and written communication skills with excellent relationship development skills
- Demonstrated ability to establish strong scientific partnership with key investigators in assigned Therapeutic Area (TA)
- Excellent knowledge of hematology especially Multiple Myeloma/Myeloid malignancies in general with a good knowledge of all products within TA
- Previous Medical Affairs experience in the US or EU pharmaceutical industry strongly
- Experience in collaborating with medical, commercial, clinical, regulatory, health outcomes, medical information, and other organizational partners
- Experience and focused training in neurovascular and neuroendovascular disease processes and therapeutics is required
List of Typical Experience For a Medical Affairs Director Resume
1
Experience For Medical Affairs Director Dermatology Resume
- MD, PharmD or PhD with knowledge and experience in medical affairs activities, with ≥ 6 y Fluent English (oral and written)
- Support or deputize GBMD in providing input into brand safety related activities for the assigned program; PSURs/DSURs
- Support new product introduction processes and product iteration as medical represented where appropriate
- Ensures reports, protocols, summaries, and all supporting medical affairs documentation used to support regulatory submissions are clear, accurate, concise, grammatically correct and auditable in English and other language as required
- Reports to Agilent VP Regulatory Affairs, Quality Assurance & Clinical Affairs
- The position has one direct report in Glostrup Denmark and indirect report(s) within the Clinical Affairs organization, as required, to support the post market surveillance and complaint vigilance process
2
Experience For Medical Affairs Director NAF Resume
- Build together with the GBMD Medical Affairs a strategy
- Provide medical scientific input for the assigned program/brand(s) to
- Deputize for the GBMD in Global Clinical Team (GCT), Global Project Team (GPT), Global Brand Team (GBT), Clinical Development Unit (CDU), CPO WebEx Alignment meetings and internal decision boards as the Medical Affairs advocate
- Contribute to talent and career development of MA and Development colleagues like MCLs, Field Medical Experts, Clinical Trial staff, through active participation in on-boarding, training and mentoring activities
- MD or PhD with knowledge with ≥ 6 years of clinical research experience preferably in the Health Industry
- Engage Key Opinion leaders, Professional Societies, Payers and Providers to
- Provide a medical perspective to clinical and regulatory organizations, provide subject matter expertise including the utilization of key clinical data and medical trends to effectively differentiate Horizon’s products and services to marketing teams to develop appropriate collateral materials
3
Experience For Regional Medical Affairs Director Resume
- Publish in peer-reviewed literature and present at national and international health meetings on topics related to Horizon’s pipeline and commercial products
- Interact and present to government, regulatory, and other stakeholders to promote enhancement of the corporation’s reputation
- Quality of medical strategies
- Alignment and integration of medical strategies and tactics in overall brand plan
- Execution of Medical education plans
- MSL KPIs (time in field, customer visits)
- Execution of data generation plans
4
Experience For Medical Affairs Director, &I Resume
- Evaluate and profile potential investigators/sites to participate in clinical development studies and/or other opportunities for research collaborations utilising Celgene’s pipeline compounds
- Support Category Medical Lead in ensuring medical compliance of Category products and activities to safeguard the interests of consumers and patients and GSK reputation –
- Compliance with relevant Codes and SOPs of all promotional claims
- Oversight of Scientific Engagement activities initiated by Category
- Medical Governance oversight for Category-led human subject research projects
- Deliver expert technical knowledge and leadership at a project level in medical activities (including MI, PV and promotional practices) to ensure best practice and achievement of project objectives based on
- Responsible for updating medical affairs procedural documents and submitting change requests when needed
- Serves as medical representative on Risk Evaluation teams. Assists investigation teams by providing medical input as needed
- Develops draft medical opinions, medical platform documents and Health Hazard Assessments for review by medical directors
5
Experience For Worldwide Medical Affairs Director Resume
- Provides initial medical input for promotional and commercial activities as requested
- Provides initial medical input for quality/regulatory customer communications, technical bulletins and quality directives
- Assist the medical director with direct customer interactions as needed
- Key opinion leader (KOL) identification and development
- Support Clinical Affairs to produce proof sources (white papers)
- Develops and implements Medical and Scientific Affairs Plans, including study and publication plans, for key products in the portfolio, in alignment with the Project Team and Lifecycle Product and Marketing Plan
6
Experience For Category Medical Affairs Director Resume
- Develops and executes study protocols for Roche Sponsored studies, in collaboration with key internal and external stakeholders, to produce high quality data to support the goals of the Medical and Scientific Affairs Plan
- Evaluates Investigator Initiated Studies (IIS), participates in Clinical Trials Review Process and is accountable for activities related to approved IISs
- Authors and assists with scientific publications, including abstracts, posters, manuscripts and whitepapers. Generates medical and scientific information materials
- Plans, develops, and generates content and delivers internal and external scientific and educational programs
- Establishes and maintains ongoing long-term collaborative peer-to-peer relationships with key thought leaders and manages Global Key Opinion Leader activities, including Advisory Boards; aligns with IBT and Regions to ensure transparency regarding KOL activities
- Contributes to, reviews and approves medical/scientific communications including marketing materials and participate in Promotional and Scientific Content Approval Processes
7
Experience For AP Regional Medical Affairs Director, IDV Resume
- Responds to unsolicited requests for information from healthcare professionals that are received either directly or indirectly through Regional organizations, in accordance with all compliance regulations and policies
- Strategic discussions regarding research to support investigator/customer initiated studies for both clinical research and HEOR
- Support operational planning/execution of MA advisory boards to understand and shape medical strategies
- Sought out by internal stakeholders as an expert on general MA matters, including external medical insights and customer initiatives
- Provide MA expertise and approval of promotional and medical materials, including but not limited to visual aids, slide presentations, etc
- Provides medical affairs support and input for new product licensing and acquisition opportunities for the Americas
- Serves as liaison for Medical and Scientific Affairs activities across diagnostics BA and Pharma Medical and Scientific partners for collaborative projects
8
Experience For Worldwide Medical Affairs Director Neuroscience Resume
- Clear understanding of regional medical practice, clinical decision-making and healthcare systems affecting patient care. Demonstrated strong understanding of clinical research trial and/or related laboratory research design and execution
- Fostering mutually productive relationships with thought leaders (TLs) and key decision makers across different types of healthcare organizations and payers in the areas of medical, education, clinical research, and health economics and outcomes research (HEOR)
- Delivering medical presentations to diverse audiences including physicians, pharmacists, nurses, and other key stakeholders aligned to appropriate payer organizations
- Providing scientific and liaison support for the involvement of TLs with company’s research activities including company-sponsored trials and facilitation of unsolicited requests for interactions related to Investigator Initiated Research (IIRs)
- Maintaining cross-functional collaboration with internal & external field teams to provide scientific expertise and function as a scientific advisor with Research, Clinical Development, Portfolio Planning, Medical Affairs, Commercial, etc
- Obtaining, assimilating, organizing and reporting appropriate competitive and scientific intelligence in a concise, clear manner, compliant with all applicable company policies, procedures and processes
- Contributing to internal training for headquarter- and field-based teams
- Assisting with the implementation and engagement of TL participation in advisory boards, consultant meetings and other scientific meetings consistent with all company policies, procedures and processes
9
Experience For Medical Affairs Director Immunology IBD Resume
- Site identification, site feasibility and physician/nurse education for both marketed products and pipeline products for company-sponsored research
- Protocol development and study management in collaboration with clinical research team for medical affairs-sponsored studies
- Travel: Approximately 60% overnight travel
- Interactions with Global Clinical Trials Organization (GCTO) and CORE (Center for Observational and Real-world Evidence) Organization in support of country portfolio of Phase II-III trials, Local Clinical Evaluations and Investigator-Initiated Studies, and to continue to attract clinical development studies to Canada
- Support to the corresponding Business Unit, Market Access and Policy and Government Affairs Group to ensure the successful management of existing products and launches of new products
10
Experience For Asia Pacific Medical Affairs Director, IDV Resume
- Role model high ethical and compliance standards to the associates within the TAs and contribute proactively to a credible image for Merck Medical Affairs to external and internal stakeholders
- Drive talent acquisition, retention and development for associates in the TAs
- Maintain cost control against budget targets for the responsible area
- Align with MA, A leaders to ensure development and execution of Americas strategic medical plans for the assigned products/TA that are aligned with the global Core Medical Plan (CMP) where applicable
- Accountable for oversight and execution of MA congress planning including collaboration across broader MA organization to ensure effective alignment and congress management
- Lead MA launch excellence and serve as launch execution liaison between MA and Commercial
List of Typical Skills For a Medical Affairs Director Resume
1
Skills For Medical Affairs Director Dermatology Resume
- Supporting speaker training initiatives
- Performing and completing administrative responsibilities
- Contributing to the development and implementation of medical education strategies and initiatives to support the company product portfolio and pipeline
- Supporting clinical research and health economics and outcomes research through numerous activities including
- Collaborating with TLs and company Medical Communications to support the development of appropriate publications and communications
- To support and guide New Business Development activities regarding opportunities for licensing and acquisition as delegated by the Neuroscience and IDV TA Lead
- The Field-Based Medical Director serves as a resource for the USMA Management Team on strategic planning and provides mentoring for other team members
- Comprehensive understanding of the compliance issues concerning medical affairs functions
- Clear understanding of regional medical practice, clinical decision-making and healthcare
2
Skills For Medical Affairs Director NAF Resume
- Lead training and/or training content for Medical Science Liaisons (MSLs) and sales representatives as required
- Key responsibilities include and are not limited to the following
- Commercial understanding of corporate and operational business issues and ability to engage and influence commercial partner
- As directed by the Global Medical Team leader, develop, conduct, or participate in therapeutic training programs for Shire internal departments
- Seek, challenge and implement ways to improve personal performance of the Category Medical Team based on enterprise thinking
- Provide medical support for MDR reporting when needed
- Assist Commercial team when working with patient customers
3
Skills For Regional Medical Affairs Director Resume
- Support execution of MA-sponsored studies including outcomes research as applicable
- Willingness to work as a team contributor
- Demonstrable humility and inquisitiveness
- Communicate and collaborate with internal and external stakeholders at all levels, from manufacturing through senior management and internationally recognized KOLs
- Willingness to advocate for a medically appropriate and patient-centric position when faced with resistance
4
Skills For Medical Affairs Director, &I Resume
- Adherence to highest ethical standards
- To develop the AP IDV Medical Plan in-line with Global TA/Disease Area Team(s) and Regional Cross-Functional TA Team, taking into account both weighted needs of the AP countries and feedback from the external scientific communities/thought leaders
- To drive the implementation of the AP IDV Medical Plan, including but not limited to data generation and publication, in partnership with Medical Directors/Advisors, Medical Education Specialists and Coordinators, on time and within budget
- To support the Neuroscience and IDV TA Lead in leading the AP IDV Integrated Value Team (IVT), as required, to develop and drive overall AP IDV strategy, while maintaining effective communications with Global Teams and Country Operating Companies
- To represent AP MAF for IDV at a Global level (GMAT, CDT ad hoc), on strategic and tactical matters, as delegated by the Neuroscience and IDV TA Lead
- To provide medical scientific and strategic inputs as requested - e.g. for future cardiometabolic pipeline and/or for established products
- Review and approve the content of EMEA communication released once draft by the communication team
5
Skills For Worldwide Medical Affairs Director Resume
- Provides accurate information about Merck products, clinical science and quality management in a balanced and credible manner consistent with the regulatory environment and Merck's ethical standards
- Experience in clinical medicine in an area relevant to the TA
- Seasoned medical director in the cancer diagnostic space, preferably with industry experience in companion diagnostics
- The role is AP based and is likely to involve extensive (~30-40%) AP and International travel
- Development and execution of Multiple Myeloma/Myeloid component of AP Medical Affairs Hematology Strategy
- Development and execution of Multiple Myeloma/Myeloid component of the MAF Annual Business Plan for hematology including data generation projects (clinical studies, registries etc..) and data dissemination projects ( Medical education, publications, MSL training etc)
- Assist Hematology TA Lead in development and management of product and T&E budget for Regional MAF activities
- MD, PharmD or PhD
6
Skills For Category Medical Affairs Director Resume
- Results orientated, entrepreneurial and self-motivated
- Familiar with all aspects of Medical Affairs
- Highly capable communicator, oral and written, with skills that are structured, well organized and concise; capable of answering ad-hoc questions without confidence and clarity
- Experience to work with external international partners
- Other medically-qualified licensure with extensive years of relevant clinical or therapeutic area experience
7
Skills For AP Regional Medical Affairs Director, IDV Resume
- Proven track record of successful leadership and progression within a medical affairs department
- Develops the team to achieve their maximum potential based on their needs and the needs of the organization through performance coaching, development and mentoring
- Demonstrated business and administrative excellence
- Experience in clinical medicine in an area relevant to the TA
- Strong knowledge of PAH, pulmonary medicine and critical care
- Management experience in pharmaceutical industry
- Form strong relationships based on credibility and trust, be able to work within teams and handle a fast-paced work environment
- MD, PharmD or PhD with knowledge and experience in medical affairs activities, with ≥ 6 year
8
Skills For Worldwide Medical Affairs Director Neuroscience Resume
- 1 – 3 years’ project management, team leader or functional line management experience
- Knowledge of US healthcare systems and clinical practices related to patient care
- Use field-based electronic or other communication tools for all aspects of job, as required
- Membership and leadership roles in specialty Professional Societies is desirable
- MD (cardiologist or pulmonologist)
- Travel within and outside of the US as needed
- To provide leadership and technical support to the incumbent’s local / regional Medical and Scientific Affairs team whilst also leading, developing and maintaining the global Medical and Scientific Affairs function
9
Skills For Medical Affairs Director Immunology IBD Resume
- The Director of Medical and Scientific Affairs provides strategic leadership
- To both the local / regional and global groups
- The role is responsible for ensuring local / regional support for appropriate brands and business but also for establishing and maintaining global best practice
- The role provides scientific and medical support for clinical trials, claims substantiation, regulatory interaction and all other activities relevant to healthcare specifically
- The role is responsible for ensuring regional medical affairs support for the brands
- An important aspect of this role is to influence and drive change internally and
- To provide Medical Affairs leadership to the incumbent’s local and regional Medical and Scientific Affairs team globally
- The Director of Medical Affairs has overall global level medical affairs responsibility and sets the direction for the local medical affairs teams across all markets
- Sets the global medical strategy for execution in all regions
10
Skills For Asia Pacific Medical Affairs Director, IDV Resume
- Works effectively with commercial, regulatory and other partners to ensure that global category plans and local initiatives are magnified and executed with excellence in the local markets from a medical standpoint
- Drives talent development for medical affairs in the regions
- Provide medical input and expertise in the analysis of study results
- Work with Regulatory and Clinical partners to prepare report on clinical investigations
- Partner with the late lifecycle management group to provide proactive medical input for lifecycle extension opportunities as appropriate
List of Typical Responsibilities For a Medical Affairs Director Resume
1
Responsibilities For Medical Affairs Director Dermatology Resume
- Aligns closely with peer colleagues in the US Commercial organization and leads/co-leads cross functional teams, providing strategic direction to support the needs of the business
- Oversee or lead special projects as assigned by VP, TA Head
- Provide scientific review of investigator sponsored research (ISR) proposals, if applicable
- Fosters a culture of 100% compliance and embodies One Astellas and the Astellas Way
- Work with Medical Business Partner to; R&D, Clinical Affairs, Regulatory Affairs, Quality & Regulatory Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education
- Ensure the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research
2
Responsibilities For Medical Affairs Director NAF Resume
- Participate in Key Governance Forums, including Global Management Boards, Cross
- Chair the Clinical Research Committee to ensure medical scientific alignment between Clinical Research and the company’s strategic needs
- To act as the EMEA MA expert and drive the strategy for a specific product or group of products
- To act as the EMEA MA expert and drive the strategy for Stelara and Guselkumab in Dermatology
- Provide input to AP business development initiatives for allocated product(s) when requested
- Medical review and approval of market research materials
3
Responsibilities For Regional Medical Affairs Director Resume
- Initiative and execution-oriented
- Certification in relevant area
- Cross-functional 360 feedback
- Maintains clinical, scientific and technical expertise in specific therapeutic areas; reviews scientific journals; attend scientific and key technical meetings; participate in internal training programs. Keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to Lifecycle and product portfolio
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